BMS 'capsule sprinkle' HIV drug gets US FDA nod

06 May 2013, BioSpectrum Bureau , BioSpectrum

Singapore: Bristol-Myers Squibb (BMS) received US FDA's approval for a supplemental new drug application (sNDA) for Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months-to-three years old and weighing at least 3.5 kg.

This approval offers a once-daily option as part of a regimen for this population and includes a 'capsule sprinkle' administration method for patients who cannot swallow capsules or tablets.

Sustiva is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was originally approved in the US in 1998 to treat HIV-1 infected children three years of age or older and weighing at least 10 kg. Sustiva is not to be taken by patients who are allergic to efavirenz, or to any of its ingredients.

"Bristol-Myers Squibb recognizes the importance of offering alternative methods of administration of HIV medicines, including for pediatric patients who cannot swallow tablets or capsules, and their caregivers who help manage their treatment," said Dr Brian Daniels, senior vice president, global development and medical affairs, BMS. "This approval is one example of our enduring commitment to the HIV patient community."